During my Family Medicine residency, I provided prenatal care, delivered babies, provided postpartum contraception, performed options counseling and abortions, and saw the infants I delivered grow into toddlers. I went on home visits to provide emotional support and end-of-life care to a magnificent woman dying of esophageal cancer. I followed my patients from the clinic to the inpatient setting and back to the clinic again. I worked to forge relationships that would hopefully keep my patients out of the hospital. I gave out my cell phone number and my e-mail address, and I welcomed phone calls and clinic walk-ins whenever there was a question or concern. I made countless calls to specialists, begging them to see my patients sooner than the next available appointment in six months. Once, for a patient with possible lung cancer on a CT scan, I made twelve phone calls to a pulmonologist before I was able to get her an appointment within an acceptable amount of time. In the Bronx community where I trained, I made certain that I was the strongest advocate for my patients, many of whom had never had anyone advocate for them before.

Now seeing uninsured patients in a mobile health clinic in Miami-Dade County, I am the safety net that wouldn’t otherwise exist. My new patients are quickly learning that I believe in their right to health care, and I will do anything to help them navigate our struggling medical system. The Washington Heights Community served by Columbia’s deeply invested residents—and this nation as a whole—needs more family physicians, not more medical administrators who have forgotten the daily realities of our patients.

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Dr. Stumbar is a 2015 graduate of Montefiore Medical Center’s Residency Program in Social and Family Medicine. She is now an Assistant Professor of Family Medicine at Florida International University in Miami.

SPRINT was a randomized controlled trial that enrolled over 9000 community-dwelling participants across 102 clinical sites in the United States. Participants had to be at least 50 years old, have a SBP between 130 and 180, and had to have "an increased risk of cardiovascular events," which the research group defined as prior cardiovascular disease (CVD) excluding stroke, chronic kidney disease (CKD), a 10-year Framingham risk score of at least 15%, or age of at least 75 years. Participants were excluded if they had diabetes or a history of a stroke. The research group provided a suggested protocol for antihypertensive medications. Participants in the intensive group had a mean SBP of 121.4 mmHg, and participants in the control group had a mean SBP of 136.2 mmHg.

The researchers' primary outcome was a composite of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from CVD, and the rate of the composite outcome was lower in the intensive group (hazard ratio 0.75 [0.64-0.89]). The number needed to treat to prevent a primary outcome event was 61. The intensive treatment group also had a higher likelihood of worsening renal function, and since the study was stopped early, it's impossible to know how likely it is that those renal effects would be irreversible. Other adverse events more common in the intensive treatment group: hypotension, syncope, and electrolyte abnormalities.

The study population may not be generalizable to your practice; it's important to note that these findings should not be extrapolated to suggest that all of our adult patients should aim for SBPs below 120. Certainly, that may be a reasonable goal for patients over the age of 50 with "an increased risk of cardiovascular events," but I suspect that many of our patients over the age of fifty with hypertension (and without diabetes) do not have those risk factors. Those patients who do meet the study parameters should still engage in patient-centered decision making regarding the risks of intensive treatment.

Dr. Lin commented on other challenges of applying this study to our patients; office blood pressure measurements, for example, are rarely done with the level of precision they were measured with in SPRINT. Aggressively adjusting medication doses based on what may be inaccurate office BP readings could potentially cause patients significant harm. Most of the time, the JNC 8 guidelines are likely to be more applicable to the patients in our offices than SPRINT's narrowly defined parameters.

Tuesday, November 17, 2015

Two research studies published today in JAMA presented compelling evidence that the 2012 U.S. Preventive Services Task Force recommendation statement that discouraged prostate specific antigen (PSA)-based screening for prostate cancer has had a significant impact on clinical practice. In one study, researchers from the American Cancer Society used data from the Surveillance, Epidemiology, and End Results registries to document an 18% relative decrease (from 37.8% to 30.8%) from 2010 to 2013 in the percentage of men age 50 years and older who reported PSA screening in the previous 12 months. In another study, a separate team of investigators found a similar decline in the prevalence of PSA screening reported in the National Health Interview Survey in men age 50 to 74 years.

For me, and for other proponents of the view that PSA screening is not effective in reducing mortality from prostate cancer and instead leads to substantial psychological and physical harms, this reversal in practice is good news. In an editorial published in the October 15th issue of American Family Physician, Dr. Vinay Prasad argued that family physicians who reduce or discontinue their use of the PSA test for screening are on solid ground:

When it comes to PSA screening, the pendulum has swung. Not only has our understanding of the benefits and harms shifted, as reflected by a continual change in guidelines away from testing, but the burden to justify screening has also swung. For decades, critics of PSA testing have shown the many unintended repercussions of the test, cautioning that our initial widespread adoption was not justified. Moving forward, it must be the proponents of screening who shoulder the burden of proof. Their task will be to show in a future randomized study whether any PSA screening algorithm can improve survival or quality of life compared with what is now the standard of care—no routine screening. Before primary care physicians consider reintroducing the PSA test, they must have proof that it improves outcomes.

In another editorial that accompanied the JAMA studies, Dr. David Penson also described the shift in practice as a "pendulum," but took the position that until a better screening test is developed, "the PSA test can be deployed more effectively (or strategically), maximizing benefit while minimizing harm." If PSA screening does in fact save some lives, Dr. Penson argued, then extending screening intervals and focusing on men who are more likely to develop "high-risk" prostate cancer could be a better approach than not screening at all:

Certainly, physicians have been overly aggressive in their approach to prostate cancer screening and treatment during the past 2 decades, but the pendulum may be swinging back the other way. It is time to accept that prostate cancer screening is not an “all-or-none” proposition and to accelerate development of personalized screening strategies that are tailored to a man’s individual risk and preferences. By doing this, it should be possible to reach some consensus around this vexing problem and ultimately help men by stopping the swinging pendulum somewhere in the middle.

SPRINT, the Systolic Blood Pressure Intervention Trial, aimed to prospectively enroll and then follow over 9000 patients during a four- to six-year time period to definitely answer that age-old blood pressure treatment question - how low should we go? Participants were at least 50 years of age, had a systolic blood pressure of at least 130, and had at least one additional risk factor for cardiovascular disease (chronic kidney disease, a Framingham score of at least 15%, and/or age of at least 75 years) but no prior history of cardiovascular disease. Patients with diabetes were excluded. The primary outcomes of interest were incidence of myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure, or cardiovascular death; they examined several other secondary outcome measures as well, including all-cause mortality and worsening chronic kidney disease.

Prior studies examining this question found no benefit for keeping systolic blood pressure under 120 but possible harm from doing so; Dr. Lin has reviewed this evidence base twice on the AFP Community Blog, in 2013 and again earlier this year. (There's also an AFP By Topic on Hypertension if you'd like to read more.) So, if the SPRINT findings are legitimate, significant changes may be quickly coming about blood pressure treatment recommendations, including the possible early retirement of JNC 8. The stakes are high.

The big announcement about these “landmark” results doesn’t actually include any “results” from the SPRINT study. You can search the news release high and low but you’ll find nary a single statistic from the study or a number related to what the researchers found.

[T]his is basically the release of conclusions without methods or even results. It hasn’t been peer reviewed. I don’t know the details....Those who conducted and funded the study can’t be the ones to judge its merit.

Doctors and reporters only had the slick NIH press release, which glistened with words such as “landmark” and “life-changing” and provided hype but little substance. It did not emphasize that the findings may only apply to a limited segment of the population...and it did not mention potential risks associated with taking multiple blood pressure drugs...

If the primary outcome turns out to be rock solid and confirmed in the future, other aspects of the study...are vulnerable to the shorter intervention period. That includes knowledge about longer term and less common adverse events, and the impact on subgroups of sicker people.

When it comes to data release of clinical trial results, the NIH should set the standards. It shouldn’t be moving the bar. In this case, one could imagine some overly pushy drug company using this data release to justify releasing more data on its own product. That leads us even further into a world where science is conducted by press release. That shouldn’t be an outcome anyone wants.

Your patients may already be reading and asking about SPRINT; how are you responding? What do you want to see from SPRINT before considering a change in how you manage patients with high blood pressure?

Update:SPRINT was just published today, and no doubt there will be a lot of discussion in the coming weeks dissecting its findings. Watch for more on this topic from the AFP Community Blog, too!

The aim of CBT is to help patients adopt more adaptive patterns of thinking and behavior to improve function and quality of life. Treatment goals are selected collaboratively with patients to determine whether progress is being made. CBT involves three core strategies applied alone or in combination, depending on the patients' needs: (1) identifying and challenging problematic thoughts and beliefs, with the goal of helping patients develop more realistic and adaptive thoughts and beliefs, (2) scheduling pleasant activities to increase environmental reinforcement, and (3) extended exposure to unpleasant thoughts, situations, or physiologic sensations to decrease avoidance and arousal associated with anxiety-eliciting stimuli.

Finding a qualified therapist many be a challenge in some communities, and CBT usually doesn't come cheaply. However, CBT for most conditions is time-limited: one session per week for 8 to 12 weeks. At $150 to 200 per session, the typical cost for a treatment course would be between $1200 and $2400.

In comparison, a one-month supply of the newer antidepressants levomilnacipran, vortioxetine, and vilazodone (which are labeled only for treatment of major depressive disorder in adults, and are often prescribed indefinitely) cost $286, $254, and $149, respectively, at the time each drug was reviewed in AFP's STEPS (Safety, Tolerability, Effectiveness, Price, and Simplicity) department. So a newer antidepressant could cost as much or more than a course of CBT in as little as 4 to 8 months.

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